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Physical & Chemical properties

Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was conducted between 20 May 2018 and 24 July 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
yes
Remarks:
In the definitive test, all vessels had a static equilibration period of 24 hours
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
n the definitive test, all vessels had a static equilibration period of 24 hours
GLP compliance:
yes (incl. certificate)
Remarks:
Date of Inspection: 18 July 2017 - 20 July 2017 Date of Issue: 28 November 2017
Type of method:
flask method
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 2955
- Expiration date of the lot/batch: 04 February 2019

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, in the dark

Water solubility:
< 0 g/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
> 6 - < 7
Details on results:
The first preliminary estimate of the water solubility at 20.0 ± 0.5 °C was less than 2.6 x 10-2 g/L. The solution had a pH of 6.5.

The second preliminary estimate of the water solubility at 20.0 ± 0.5 °C was less than 2.7 x 10-2 g/L. The solution had a pH of 6.1.

In the definitive test, the appearance of samples is shown in the Table 7, below, and the concentration (g/L) of test item in the sample solutions is shown in Table 8, below.

Table 7

Sample Number

Appearance of Sample Solution

1

A distinct Tyndall beam, i.e. much dispersed, undissolved test item, observed within a clear/colourless solution.

2

Clear, colourless solution, with a faint Tyndall beam and some small, colourless globules moving near the bottom of the solution

3

Clear, colourless solution, with an extremely faint Tyndall beam and a few small colourless globules floating near the bottom of the solution

Table 8

Sample Number

Time Shaken at 30°C (hours)

Concentration (g/L)

Solution pH

1

72

2000

6.6

2

72

2000

6.6

3

72

2000

6.9

As the test item is a liquid, the flask shaking test was performed.

In the preliminary tests, the test item was noted to form extremely fine dispersions in water, which could not be cleaned-up using centrifugation and filtration. A HPLC method was developed for the test item; however, the limit of detection was fairly high.

Therefore, it was considered that definitive testing using visual inspection, would be more appropriate to attain an accurate limit of solubility.

Conclusions:
The water solubility of the test item has been determined to be less than 3 x 10-5 g/L at 20.0 ± 0.5 °C.
Executive summary:

Water solubility was determined to be less than 3 x 10 ^-5 g/L of solution at 20.0 ± 0.5 °C, using the flask method, designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for the Testing of Chemicals, 27 July 1995.

Description of key information

The water solubility of the test item has been determined to be less than 3 x 10^-5 g/L at 20.0 ± 0.5 °C.

Key value for chemical safety assessment

Water solubility:
0 g/L
at the temperature of:
20 °C

Additional information

Water solubility was determined to be less than 3 x 10 ^-5 g/L of solution at 20.0 ± 0.5 °C, using the flask method, designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for the Testing of Chemicals, 27 July 1995.

As the test item is a liquid, the flask shaking test was performed.

In the preliminary tests, the test item was noted to form extremely fine dispersions in water, which could not be cleaned-up using centrifugation and filtration. A HPLC method was developed for the test item; however, the limit of detection was fairly high.

Therefore, it was considered that definitive testing using visual inspection, would be more appropriate to attain an accurate limit of solubility.

The maximum value of water solubility (3 x 10^-5 g/L) was input as the key value.